Specimen Requirements

Clinical Signifigance

BCR-ABL1 p210: Monitoring tyrosine kinase therapy in patients with CML with known e13a2 or e14a2 fusion transcripts. The transcript level for the major breakpoint (p210)is reported as apercentage of BCR-ABL1:ABL1 ratio by using theInternational Scale (IS). BCR-ABL1 p190: Monitoring therapy in patients with CML or other BCR-ABL1 positive neoplasms with known ela2 fusion trasncript. The transcript level for the minor breakpoint (p190) is reported as the NCN% ratio of BCR-ABL1 to ABL1.

Cause for Rejection

Retention

One week - whole blood. RNA - 2 years.

Comments

This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

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